Back to jobsRepresent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development, and product safety teams as appropriate.
In collaboration with Global Regulatory Leads and Core Labeling Teams (CLTs): create, revise, and maintain Company Core Data Sheets (CCDS) for Alnylam’s products.
Develop labeling strategies and Target Label Profiles.
Provide strategic guidance to Core Labeling Teams regarding new and revised labeling regulations, competitor labeling, and labeling trends.
Review and communicate impact of changes in health authority labelling legislation or guidelines on Alnylam’s products[KM1.1].
Lead with development and maintenance of regional labeling that aligns with the CCDS and meets the requirements of health authorities.
Lead with preparation of responses to labeling-related queries from health authorities.
Coordinate labeling activities (e.g., labeling supplements, new labeling development) with internal and external alliance partners as required.
Partner with Regulatory Technology and Operations and Supply Chain to ensure submission-ready labeling components comply with regulatory requirements. Assist with preparation of submissions to health authorities, as needed.
Track data sources supporting labeling claims, history of labeling negotiations and changes, and reasons for differences in local labeling.
Support the growth of the Global Labeling function and help design/build systems and processes.
